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  • Regulatory NewsRegulatory News

    House spending bill would give FDA drug recall authority

    The US House Committee on Appropriations approved a $3.212 billion budget for the Food and Drug Administration (FDA) on a voice vote Thursday. The budgeted amount is part of the fiscal year 2021 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill, which moved out of the Appropriations Committee on a voice vote.   The bill will now be placed on the calendar for consideration by the full House of Representatives. (RELATED: House prop...
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    EU agencies urge sponsors to ensure post-Brexit compliance with clinical trial rules

    In a notice issued on Thursday, the European Commission, European Medicines Agency and Heads of Medicines Agencies reminded clinical trial sponsors that they must comply with EU clinical trial rules following the Brexit transition period that expires on 31 December 2020.   With the deadline to extend the transition period now passed, “There is no possibility for further extension beyond that date,” the agencies write, pointing trial sponsors to the Commission’s Brexit ...
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    FDA finalizes guidance on broader cancer trial eligibility

    In four final guidances published today, the US Food and Drug Administration (FDA) outlines cancer trial eligibility criteria considerations for individuals with several specific clinical conditions. Another guidance addresses minimum age considerations for inclusion of pediatric patients in cancer clinical trials.   The guidances, issued jointly by FDA’s Centers for Drug Evaluation and Research and Biologics Evaluation and Research (CDER and CBER), provide considerati...
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    FDA looks to resume domestic inspections this month

    Months after halting most inspections amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) on Friday said it plans to resume on-site domestic inspections beginning the week of 20 July 2020.   As a safety measure, FDA will pre-announce all inspections, save for retail tobacco inspections, for the foreseeable future.   The announcement comes nearly two months after the agency said it will implement a phased approach to restartin...
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    Marks on COVID-19 vaccine efficacy, EUAs and challenge trials

    A week after the US Food and Drug Administration (FDA) issued guidance on vaccines to prevent coronavirus disease (COVID-19), Peter Marks, director of the Center for Biologics Evaluation and Research, shed light on the reasoning behind the agency’s 50% efficacy threshold and where the agency stands on challenge trials and emergency use authorizations (EUAs).   Efficacy and approval   In its guidance, FDA said it expected sponsors to demonstrate a vaccine is at leas...
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    ICMRA outlines shape of Phase 3 COVID-19 vaccine trials

    A new report provides a roadmap for Phase 3 clinical trials for developers of candidate vaccines for the novel coronavirus SARS-CoV-2, the virus that causes COVID-19. The report indicates which clinical and preclinical data will indicate a vaccine is ready for Phase 3 trials; it also lays out key considerations in designing Phase 3 clinical trials of vaccines for COVID-19.   The report reflects consensus reached at a 22 June 2020 teleconference convened by the US Foo...
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    French notified body GMED designated under MDR

    France’s GMED on Wednesday became the country’s first notified body designated under the Medical Devices Regulation (MDR) and the 15 th overall with less than a year before the regulation’s new date of application.   The Paris-based GMED is the sixth to be designated in 2020, following the designation of Swedish notified body Intertek in May. (RELATED: MDR delay official as industry calls to push back IVDR , Regulatory Focus 24 April 2020; Swedish notified bo...
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    NIH kicks off COVID-19 vaccine, monoclonal antibody research network

    The National Institutes of Health (NIH) today announced the kickoff of a national clinical trials network to test vaccines and other treatments that could prevent infection with SARS-CoV2, the virus that causes infection with the novel coronavirus COVID-19.   The network has been established by the National Institute of Allergy and Infectious Diseases (NIAID) through the merger of four previously existing clinical trials networks that focused on HIV/AIDS.   “Star...
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    More metformin recalled for NDMA; 6 firms now affected

    Two manufacturers have announced voluntary recalls of metformin formulations containing elevated levels of a potential carcinogen.   Granules Pharmaceuticals, based in Virginia, has issued a recall for its extended-release metformin, although just one of 12 batches tested exceeded acceptable levels of N-nitrosodimethylamine (NDMA) in the firm’s testing. The recall includes 100- and 500-count bottles of 750 mg metformin tablets.   Separately, India-based Lupin Pha...
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    Unified agenda: FDA publishes lengthy to-do list

    Two final rules top the Spring 2020 regulatory agenda for the US Food and Drug Administration (FDA), addressing the importation of prescription drugs and the de novo classification process for medical devices. The agency’s unified agenda overall is mammoth and includes 26 final rules as well as 52 proposed rules, some of which have been carried over from previous agendas.   The importation of prescription drugs continues to be among deregulatory priorities for the Tr...
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    Device manufacturers warned by FDA for consumer complaint handling

    The US Food and Drug Administration (FDA) today released warning letters to two medical device manufacturers who, according to the agency, failed to address serious consumer complaints adequately. The agency also warned an India-based manufacturer of active pharmaceutical ingredients (API).     Luminex Corporation   Texas-based Luminex Corporation manufactures microsphere-based and PCR-based multiplexing systems; the firm was warned after a February 2020 inspec...
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    House proposes $3.2 billion for FDA in FY 2021

    On Monday, the US House Committee on Appropriations’ Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies held a markup session for fiscal year 2021 appropriations.   Of the total budget of $23.98 billion – a 2.3% increase from the prior fiscal year -- the bill allocates $3.212 billion for the Food and Drug Administration (FDA). This amount is an increase of $40.8 million over the prior fiscal year’s approximate $3.2 bill...